Add-on treatment with pregabalin for partial seizures with or without generalisation: pooled data analysis of four randomised placebo-controlled trials.
Pooled data analysis was performed on individual data from 807 pregabalin- and 367 placebo-treated patients with treatment-resistant partial seizures with or without generalization from four placebo-controlled studies evaluating the short-term efficacy, safety and tolerability of add-on pregabalin 150-600 mg/day. Short-term add-on treatment with pregabalin resulted in statistically significant reductions from baseline in seizure frequency and statistically significantly higher responder rates over placebo (OR 5.93 [95% CI 4.10, 8.57]). Its overall tolerability was good, with an OR of withdrawing from the study due to any reason of 1.71 (95% CIs 1.24, 2.35). The most commonly reported AEs were dizziness and somnolence, however, they were most pronounced during the first week of treatment, followed by a sharp fall in incidences across all dosing groups to <5% from Week 2 and onwards. Weight gain, reported by 5.4-17.1% of patients across pregabalin dosing groups, appeared to be dose-related, but it led to study withdrawal in only 0.74% (6 out of 810) pregabalin-treated subjects. Our analysis suggests that pregabalin has a robust efficacy and good tolerability demonstrated in a study population more treatment-refractory compared to the one enrolled into short-term studies of other new antiepileptic drugs.
Gil-Nagel
Antonio
A
Neurology Department, Ruber International Hospital, La Maso 38, 28034 Madrid, Spain. agnagel@ya.com
Zaccara
Gaetano
G
Baldinetti
Francesca
F
Leon
Teresa
T
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D000927:Anticonvulsants / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004828:Epilepsies, Partial / Q000188:drug therapy*; D004829:Epilepsy, Generalized / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D000069583:Pregabalin; D016032:Randomized Controlled Trials as Topic; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult; D005680:gamma-Aminobutyric Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use
D000927:Anticonvulsants; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid